POLICY BRIEFING – WEEK IN REVIEW
It is no secret that the Food and Drug Administration (FDA) has been involved in controversy since the pandemic started, from the White House decrying regulations to retracted statements on therapeutic options. As such, it comes as no surprise that, "vaccine confidence is at an all-time low," according to Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. In an effort to restore confidence, Dr. Marks partnered with the American Medical Association through a webinar, in order to outline the agency's meticulous approach to product development.
During this session, Dr. Marks outlined some key components of the FDA's strategy. To increase transparency, the FDA requires vaccine candidates make their data public before advisory committee meetings. He also discussed the pathways for product approval by Emergency Use Authorization (EUA) or biologic license application (BLA), as well as the trial data for current applicants and data requirements for consideration. He emphasized the reliance on large data sets and substantial evidence of compelling advocacy. The interview ended with a projected timeline for roll out, with frontline workers possibly seeing a vaccine product by the end of the calendar year, but called this merely, "informed speculation." Various. 14 October 2020.
Late last week GenMark Diagnostics, a laboratory test manufacturer, was granted an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its ePlex Respiratory Antigen Panel 2, a new rapid molecular test that can distinguish between over twenty viruses and bacterias, including the coronavirus SARS-CoV-2 that causes covid-19.
In explaining the decision, the FDA acknowledged that there were other products that test for these same pathogens, but currently no multiplexed tests for "simultaneous qualitative detection and differentiation of nucleic acids" and that a need for such differentiation existed.
Like many other coronavirus tests, this one uses a nasopharyngeal swab sample collected by a healthcare provider and analyzed in a special medium. Because of the method of evaluation, this device is not intended to be a point-of-care product; this means that tests will be run in centralized laboratories that have samples delivered to them. This process can lead to substantial delays between the acquisition of a test and the results. The Food and Drug Administration. 12 October 2020.